Key Strengths of STAR AF II Exclusively persistent AF (80% in - - PDF document

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Key Strengths of STAR AF II Exclusively persistent AF (80% in - - PDF document

8/16/2016 Disclosures Moderate Support (research) Biosense Webster Is Durable PVI Enough for Ablation of Persistent AF? Bayer Inc CHRS 2016, San Francisco Boehringer Ingelheim Medtronic Inc Advisory Board, Speakers fees


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8/16/2016 1

Is Durable PVI Enough for Ablation of Persistent AF? CHRS 2016, San Francisco

Atul Verma, MD FRCPC FHRS

Director, Heart Rhythm Program Southlake Regional Health Centre Newmarket, Ontario, Canada Chair, Heart Rhythm Working Group, Cardiovascular Care Network Associate Professor, University of Toronto Adjunct Professor, McGill University

Disclosures

  • Moderate Support (research)
  • Biosense Webster
  • Bayer Inc
  • Boehringer Ingelheim
  • Medtronic Inc
  • Advisory Board, Speakers fees
  • Bayer Inc
  • Biosense Webster
  • Boehringer Ingelheim
  • Medtronic Inc
  • St Jude Medical Inc

Key Strengths of STAR AF II

  • Exclusively persistent AF (80% in continuous AF > 6 months)
  • Large clinical study (589 patients in 48 centers)
  • Rigorous follow‐up (18 months, Holters, at least weekly TTM for

entire 18 months)

  • Arms chosen based on most common techniques of ablation for

persistent AF: PVI, PVI+CFE, and PVI+LINES (1)

1 Calkins et al, Consensus Guidelines Catheter Ablation, Heart Rhythm 2012

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SLIDE 2

8/16/2016 2

Purpose

  • To compare the efficacy of three different AF ablation

strategies in patients with persistent AF*: (1) Pulmonary vein isolation (PVI) alone (2) PVI plus complex fractionated electrograms (PVI+CFE) (3) PVI plus linear ablation (PVI+Lines).

* Defined as AF episode lasting > 7 days but less than 3 years

Methods – Ablation Strategy

Linear strategy CFE strategy ** Pre‐specified pacing manoeuvres to determine linear block ** Complete elimination of CFE (not defragmentation) until termination

  • r all CFE regions eliminated.

Results ‐ Ablation characteristics

  • 79% of patients presented to EP lab in spontaneous AF
  • Successful PV isolation obtained in 97% of all patients (all groups)
  • CFE were eliminated in 80% of patients

– 11% not ablated because AF non‐inducible after PVI – 9% all CFE could not be eliminated

  • Both lines with block achieved in 74% of patients

– Roof line only 93% – Mitral line only 75%

Results ‐ Primary Outcome

p=0.15 Documented AF > 30 seconds after one procedure with or without AAD 59% 48% 44%

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8/16/2016 3

AF Burden Reduction

Burden calculation based on maximum of burden calculated from all follow‐up Holters or # of weeks with at least one TTM of AF or number of days in AF from CRF

Percentage of Patients with PV Recovery at Repeat Procedure

77 86 83 84

10 20 30 40 50 60 70 80 90 100

PVI PVI+CFE PVI+Lines Total

Patients with >1 recovered PV (%) * 80% of PVI+Lines pts also had gap in one or more lines, 63% of PVI+CFE had more CFE to ablate

Freedom from AF/AT after 1 procedure based on linear block achieved Freedom from AF/AT after 1 procedure based on all CFE ablated

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CHASE AF Trial – Volger et al, JACC 2015

  • Randomized comparison of full stepwise approach

(PVI+CFE+LINES) vs PVI alone + cardioversion for patients with persistent AF

  • All patients received PVI first – any patient terminating

after PVI alone was excluded

  • The stepwise patients received:
  • 100% got LA defragmentation
  • 81% got CS defragmentation
  • 91% got RA defragmentation
  • 36% got linear ablation for AT

13

CHASE AF Trial

14

CHASE AF - Results

15

** Still no difference when multiple procedures taken into account

Meta-Analysis – PVI or PVI+ for PeAF

16

Scott et al, Europace 2016

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8/16/2016 5

Meta-Analysis – PVI+CFAE vs PVI

17

Meta-Analysis – PVI+LALA vs PVI

18

Cryoballoon for Persistent AF

  • 100 patients

undergoing ablation with Artic Front Advance balloon technology with persistent AF

  • Follow-up at 1,3,6, and

12 months

  • 7 day Holter at 3 and 6

months and 24 hour Holter at 12 months

19

Koektuerk et al, Circ EP 2015

Cryoballoon for Persistent AF

20

Over mean follow-up of 11 +/- 6 months, 67% of patients were in sinus rhythm

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8/16/2016 6

Cryoballoon for Persistent AF

  • 393 patients undergoing

ablation with Artic Front Advance balloon technology

  • Only 62 (16%) had

persistent AF

  • Success in 61.3%
  • Persistent AF was one of

three multivariable predictors of recurrence

21

Irfan et al, Europace 2015

Does this prove that PVI is enough for persistent AF?

  • NO.
  • Success rates are still low – about 60% in all of these

studies

  • Many of these patients required more than one procedure
  • We can and should be able to do better
  • Better patient selection?
  • Need to identify novel targets for ablation more effective

than CFAE or linear ablation

  • Ultrasound anatomy reconstruction
  • Up to 115,000 points collected per

minute

  • 3D surface is algorithmically

reconstructed from ultrasound point set

  • Dipole density mapping
  • Intracardiac unipolar voltage sampled

at 150,000/sec

  • Forward and inverse algorithms

applied to derive dipole density

  • Multiple map types to view and

assess activation patterns

Image guided ablation strategy

48 Ultrasound transducers 48 Engineered electrodes

Identify and locate arrhythmic mechanisms

AcQMap™ High Resolution Imaging and Mapping System

LAA LSPV LIPV RSPV RIPV LAA LSPV LIPV RSPV RIPV LAA LSPV LIPV RSPV RIPV

Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

AcQMap is not for sale in the United States 24

AcQMap of Pre-PVI AF

  • Pre-PVI map showed an even

mix of focal breakthrough and confined zones of irregular- rotational conduction anterior to the right PV antrum and between the inferior aspect of right and left PV antrums.

  • “Irregular rotational” refers

to multidirectional spiral conduction around a confined zone.

LSPV RSPV RIPV LAA RSPV MV LIPV

LSPV

LAA

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SLIDE 7

8/16/2016 7

NOVEL ALGORITHM OF DOMINANT FREQUENCY & ELECTROGRAM PATTERNS TO IDENTIFY FOCAL SOURCES AND ROTATIONAL PATTERNS DURING HUMAN PERSISTENT ATRIAL FIBRILLATION

AtulVerma, MD, FHRS, Thomas Deneke, MD, PhD, Yariv A. Amos, Msc, Roy Urman, BSc, Philipp Halbfass, MD, Karin M. Netwich, MD, Erik Wissner, MD, FHRS, Karl- Heinz Kuck, MD, FHRS and Roland, TilzMD.

SOUTHLAKE REGIONAL HEALTH CENTRE, Newmarket, Ontario, Canada; HEART CENTER BAD NEUSTADT, Bad Neustadt, Germany; BIOSENSE WEBSTER, Haifa, Israel; ASKLEPIOS KLINIK ST. GEORG, Hamburg, Germany

Automated methods may identify areas of interest during ablation of persistent atrial fibrillation (AF). We sought to determine if an algorithm based on dominant frequency (DF) and electrogram (EGM) patterns during persistent AF could be used to identify focal sources and rotational patterns. Maps of persistent AF were acquired using a multi-electrode basket catheter. The CARTOFINDER™ algorithm filters all unipolar EGMs for quality, reduces far-field ventricular artifacts and annotates the timing

  • f the activation wave front. DF analysis was

performed and the pattern was classified as homogenous (<0.5 Hz) or heterogeneous (>0.5 Hz) & stable (regular/no variation over 30 sec) or unstable (random variation). The algorithm can identify QS EGM patterns and “regular” sequential atrial activation gradients occupying >50% of the cycle length (CL) suggesting rotational wave

  • fronts. All 4D activation maps were reviewed

by two blinded independent adjudicators to visually identify focal sources and rotational wave fronts & only those agreed upon by both reviewers were included for analysis. A CARTOFINDER™ algorithm based on DF, LAT and EGM patterns correlated well with visually confirmed regions of interest during human persistent AF. These patterns could prospectively identify regions of interest with a reasonably high predictive value. Rotational activations covered 67±8% of the local CL with a mean of 3.0±2.7 rotations. Rotational wave front patterns were related to areas of homogeneous-stable DF spatiotemporal stability (variance 0.46± 0.17Hz) and with sequential EGM activation gradients . Focal sources were related to areas of heterogeneous-stable DF spatiotemporal stability (variance 0.58±0.30Hz) and with a consistent QS EGM

  • pattern. DF temporal stability between RAPs

and sources was statistically significantly different (unpaired t test, p<0.000001)

CARTOFINDER™ Algorithm sensitivity and specificity with respect to human expert identification Foci Sensitivity/Specificity 89% / 77% RAP Sensitivity / Specificity 82% / 70%

ABSTRACT METHODS The CARTOFINDER™ system identified 34±14% of the basket EGMs were adequate for analysis when positioned in the left atrium (LA) and 60±15% were adequate in the right atrium (RA). 20 patients were analyzed, rotational activations were identified by the experts in 27/70 (39%) of the LA maps and 24/51 (47%)

  • f the RA maps. Focal sources were

identified in 47/70 (67%) of the LA maps and 46/51 (90%) of the RA maps. . RESULTS Focal Source Rotational Activation Pattern CONCLUSIONS

Number of focal sources found in analysis of 121 maps Number of rotational activation wave front found in analysis of 121 maps

TOUCH AF Trial – Verma et al, pending

  • Contact force sensing for ablation of persistent AF
  • Allowed wide antral PVI and roof line only
  • Randomized operators to CF-guided vs CF-blinded

approach

  • Final analysis not yet complete, BUT…..
  • Average contact force was 15 grams for both arms
  • Overall success rate was 78% with fewer than 20% of

patients requiring second procedure

26

Conclusions

  • PVI seems to be the cornerstone for any ablation

procedure for persistent AF

  • Success rates with PVI alone seem to be stuck around

60%

  • Many will require more than one procedure
  • Mapping AF may help us to realize novel targets for

ablation and improve success rates